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Satoshi Matsuyama,1 Tempei Otsubo,2 Keisuke Nomoto,1 Shingo Higa,1 Osamu Takashio3 1Medical Affairs, Viatris Pharmaceuticals Japan Inc., Tokyo, Japan; 2Department of Psychosomatic and Psychiatric Medicine, Tokyo Women’s Medical University Adachi Medical Center, Tokyo, Japan; 3Department of Neuropsychiatry, Showa University East Hospital, Tokyo, JapanCorrespondence: Satoshi Matsuyama, Medical Affairs, Viatris Pharmaceuticals Japan Inc., Holland Hills Mori Tower, 5-11-2 Toranomon, Minato-ku, Tokyo, 105-0001, Japan, Tel +81-3-5656-0400, Fax +81-3-5656-0603, Email satoshi.matsuyama@viatris.comPurpose: Generalized anxiety disorder (GAD) is among the most prevalent and highly disabling mental health conditions that negatively impacts patient’s quality of life (QOL) and disrupts activities of daily living. However, the recognition of GAD is difficult due to substantial overlap with other mental disorders. The purpose of this study was to estimate the prevalence of GAD, assess QOL of probable GAD patients in Japan, and gain insights on the status of visiting medical institutions as well as their recognition/awareness of the disorder.Patients and Methods: We conducted a web-based cross-sectional survey of 20,009 participants using a questionnaire with approximately 30 single/multiple choice or open-ended questions in Japanese.Results: Overall prevalence of GAD based on Generalized Anxiety Disorder 7-item (GAD-7) cutoff score of ≥ 10 and questionnaires developed with reference to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria was 7.6% (n=1530) and 6.0% (n=1197), respectively. The degree of coincidence between GAD diagnosis by DSM-5 criteria and GAD-7 scores was moderate (Cohen’s Kappa=0.47, p< 0.01). Younger people reported a substantially higher prevalence of GAD compared to older. QOL scores assessed using EuroQol 5 dimensions 5-level and EuroQol Visual Analog Scale were substantially lower in probable GAD patients than those with GAD-7< 10. Anxiety/depression and pain/discomfort were the most prevalent issues and depression was the most reported comorbidity for the probable GAD patients. Probable GAD patients “currently visiting medical institutions” for anxiety or other mental issues were 27.6% (422/1530); a majority had seen specialists. Most of the probable GAD patients had never heard of the disease.Conclusion: We found higher prevalence of GAD and lower QOL of probable GAD patients in Japan. There is a need for creating awareness about GAD among the general population and developing clinical guidelines on GAD in Japan so that physicians can educate their patients.Keywords: GAD-7, generalized anxiety disorder, Japan, prevalence, quality of life

Keisuke Nomoto,1 Osamu Takashio,2 Satoshi Matsuyama,1 Shingo Higa,1 Tempei Otsubo3 1Medical Affairs, Viatris Pharmaceuticals Japan Inc., Tokyo, Japan; 2Department of Neuropsychiatry, Showa University East Hospital, Tokyo, Japan; 3Department of Psychosomatic and Psychiatric Medicine, Tokyo Women’s Medical University Adachi Medical Center, Tokyo, JapanCorrespondence: Keisuke Nomoto, Medical Affairs, Viatris Pharmaceuticals Japan Inc., Holland Hills Mori Tower, 5-11-2 Toranomon, Minato-ku, Tokyo, 105-0001, Japan, Tel +81-3-5656-0400, Fax +81-3-5656-0603, Email keisuke.nomoto@viatris.comPurpose: Generalized anxiety disorder (GAD) is a suboptimally managed chronic recurring psychiatric condition with a lifetime prevalence of 2.6% in Japan. We assessed the current status of GAD management in Japan.Patients and Methods: This was an observational, cross-sectional study conducted through an anonymous web-based survey in Japan from December 12– 16, 2022. Psychiatrists and psychosomatic medicine physicians who agreed to participate and saw ≥ 10 outpatients in the previous month were eligible. Survey questionnaire comprised 37 single/multiple choice, numerical entry, or open-ended questions in Japanese.Results: Among 509 participants (493 psychiatrists and 16 psychosomatic medicine physicians), 96.9% were aware of GAD. On average, 12.4 outpatients and 1.0 inpatient were diagnosed with GAD per physician per month. Of 433 physicians having patients diagnosed with GAD, 46.9% used operational diagnostic tools; among these, DSM-5 diagnostic criteria were used by 81.5% physicians. The majority (54.7%) of participants did not use a self-administered rating scale; depression scales were used more than anxiety scales. Among these 433 physicians, 96.8% used selective serotonin reuptake inhibitors for GAD management, and 79.2% used it as the first choice; of 431 physicians who prescribed drug therapy, 54.3% gave antidepressant monotherapy as first choice. The most frequent symptom in patients diagnosed with GAD was excessive anxiety/worry (96.5%); depression was the most commonly reported comorbidity (84.3%) as per physicians aware of GAD (N=508).Conclusion: This study illustrates that although GAD awareness is high among Japanese psychiatric specialists, GAD is not frequently diagnosed using operational diagnostic approaches. Due to a lack of Japanese guidelines for GAD diagnosis and treatment, diverse international guidelines are followed, with similar treatment paradigms as that of depression. This may not be an optimal approach given cultural/geographical differences. These findings highlight the need for uniform diagnosis and treatment recommendations for GAD management in Japan.Clinical Trial Registration: UMIN-CTR: UMIN000049572.Keywords: anxiety, GAD, psychiatrist, psychosomatic medicine physician, survey